Complaints about Timing of FDA Panel Meeting to Consider Safety of Essure Birth Control

The Food and Drug Administration (FDA) has scheduled a September 24 panel meeting to consider the safety of Bayer HealthCare’s Essure birth control device. But women calling for the device’s removal from the market say the meeting date was chosen to coincide with Pope Francis’s address to Congress and will draw attention away from the meeting.

The FDA is convening the meeting in response to complaints of clinical trial fraud and serious side effects associated with Essure, FierceMedicalDevices reports.The pope will deliver an address to Congress on September 24—the date of the FDA panel meeting. Angela Desa-Lynch, an administrator for the Facebook group Essure Problems told the Catholic News Agency that the FDA was aware of the scheduling convergence, though the agency denies the scheduling conflict was intentional. “[T]he meeting was not timed in any way with the Pope’s address to Congress,” agency spokeswoman Deborah Kotz told the news agency in an email. The meeting date was announced on June 24, while the pope’s itinerary was not released until June 30, FierceMedicalDevices reports. But the Catholic News Agency said the pope’s September 24 address to Congress was publicized as early as February 5.

Essure is a nonsurgical permanent birth control method that received FDA approval in November 2002. The implant procedure is done on an outpatient basis in a doctor’s office. Small, nickel-titanium coils are inserted through the vagina into the woman’s fallopian tubes. Scar tissue forms, blocking the tubes and preventing pregnancy. Once blockage is confirmed, the method is considered 99.83 percent effective, National Public Radio (NPR) reports. But women have reported a variety of injuries and side effects they say were caused by Essure. These include abdominal pain, nickel allergy, fatigue, migraines, joint pain, back pain, heavy periods, unintended pregnancies, and ectopic pregnancies (where the embryo implants outside the uterus). Some of the devices have migrated from the fallopian tubes into the woman’s abdomen, and, rarely, the coil has been expelled from the woman’s body.

In April, the FDA said it would investigate Essure because of complaints of fraud during the clinical trial and reports of serious side effects. The FDA has received more than 5,000 complaints about Essure since its approval. In May, Bayer released data from a long-term study to support the safety and efficacy of Essure. According to Bayer, the device caused pelvic pain in only 7 percent of participants in the five-year follow-up. But a New York Times article called this data into question, citing long-term trial results published in the Journal of Minimally Invasive Gynecology. According to the Times, only 366 out of 518 original study participants were followed for the full five years, according to the Times. The women who were tracked cited a number of problems attributed to the device, including unusually heavy periods and recurrent pelvic pain.

The FDA meeting will be open to the public. The agency said any interested party may present material in writing or may request time to speak during a public comment session.

The post Complaints about Timing of FDA Panel Meeting to Consider Safety of Essure Birth Control appeared first on Parker Waichman -

from Parker Waichman http://www.yourlawyer.com/blog/complaints-about-timing-of-fda-panel-meeting-to-consider-safety-of-essure-birth-control/